Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a Chinese pharmaceutical company, has announced that China’s National Medical Products Administration (NMPA) has accepted for review its market approval filing for ZSP1273, a Category 1 drug candidate and a potential treatment for influenza A.
ZSP1273 is recognized as the first small-molecule RNA polymerase inhibitor to be approved for clinical study in China. Pre-clinical studies have demonstrated that ZSP1273 is significantly more effective than nucleic acid endonuclease inhibitor baloxavir marboxil and neuraminidase inhibitor oseltamivir in inhibiting various Influenza A viruses. The drug has also shown a strong inhibitory effect on oseltamivir-resistant, baloxavir marboxil-resistant, and highly pathogenic avian influenza virus strains. Phase III studies have indicated that ZSP1273 outperformed the placebo group in primary endpoint indicators, such as time to alleviation of seven flu symptoms (TTAS), and secondary endpoint indicators including time to relief of single system or single symptom, and virological indicators like decreased viral load, time to virus seroconversion, and the proportion of subjects with virus seroconversion. The drug also exhibited a good tolerability profile.- Flcube.com
